Clinical Development Scientist
3 days ago
Astellas Pharma Inc. is seeking a highly skilled Clinical Development Scientist to join our team. As a key member of our clinical development team, you will be responsible for leading the development and execution of clinical trials from protocol development to study close-out.
Key Responsibilities- Protocol Development: Develop and maintain clinical trial protocols, investigator brochures, and clinical study reports.
- Study Execution: Oversee the execution of clinical trials, including site identification and management, data management, and monitoring.
- Regulatory Affairs: Collaborate with regulatory affairs teams to ensure compliance with regulatory requirements and guidelines.
- Medical Monitoring: Perform medical monitoring activities, including review and analysis of patient data, and generation of reports.
- Team Collaboration: Work closely with cross-functional teams, including medical affairs, clinical operations, and data sciences, to ensure seamless execution of clinical trials.
- Communication: Develop and maintain effective communication with internal stakeholders, including study teams, medical affairs, and regulatory affairs, as well as external stakeholders, including investigators, researchers, and health authorities.
- Strategic Planning: Contribute to the development of strategic plans for clinical trials, including study design, protocol development, and resource allocation.
- Training and Development: Provide training and development opportunities for clinical trial staff, including investigators, researchers, and study coordinators.
- Education: Advanced degree in a relevant scientific discipline, such as health science or clinical discipline.
- Experience: Typically 7-10 years of clinical, scientific/research, pathology, or industry-related experience, or a combination of academia and industry experience.
- Skills: Strong computer skills, including MS Office Suite and industry-standard software, such as electronic data capture systems and data analysis software. Excellent collaboration and interpersonal communication skills, with the ability to interact with all levels of internal stakeholders and key functional areas.
- Knowledge: Thorough knowledge and demonstrated expertise in biotechnology/pharmaceutical industry-related to clinical drug development, including regulatory submissions (INDs, BLAs, NDAs) with US and OUS regulatory agencies.
- Travel: Ability to travel ~25%, with international travel at times.
- Education: D. or PharmD degree, or other relevant Master's degree.
- Skills: Knowledge and proficiency related to Medical Affairs activities, including registries.
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